Clinical trial · Interventional
BIBW 2992 and Letrozole in Hormonoresistant Metastatic Breast Cancer
A Phase II Study of BIBW 2992 Administration in Patients With Hormone Refractory Metastatic Breast Cancer
NCT00708214CI-TRIAL-00013254completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Progression-free rate after 16 weeks of BIBW 2992 administration in association with letrozole
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BIBW 2992
- description
- To study BIBW 2992 in association with letrozole in hormonoresistant metastatic breast cancer
- interventionNames
- Drug: BIBW 2992
- Drug: Letrozole
- type
- OTHER
- label
- Letrozole
- description
- Hormonotherapy for metastatic breast cancer
- interventionNames
- Drug: BIBW 2992
- Drug: Letrozole
Primary outcomes (1)
- measure
- Percentage of Progression Free Participants After 16 Weeks of Treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Female patients with histologically proven breast adenocarcinoma * Presence of metastatic disease No more than 2 prior chemotherapy regimens for metastatic disease, which could include trastuzumab Patients must currently be on letrozole and developed acquired resistance as defined by disease progression on letrozole following previous response (partial response or better, stable disease superior or equal to 24 weeks) Diagnosis of disease progression inferior or equal to 6 weeks prior to trial entrydefined as: 1. Increase in the number of bone lesions on bone scan or on MRI AND/OR 2. Increased pain in an area of known bony metastasis AND superior or equal to 2 serial elevations in CA 15.3 AND/OR 3. Progression according to RECIST criteria on CT scan, MRI, or x-ray Patients must have documented menopause confirmed by estradiol level inferior to 11 pg/ml Exclusion criteria: * Premenopausal patients * Rapidly progressive disease in major organs (i.e. lymphangitic spread in the lung and/or bulky liver metastasis) Patient with brain metastasis Significant cardiovascular diseases Previous treatment with an EGFR and/or HER-2 inhibiting drug(patients who received trastuzumab with chemotherapy but not with letrozole can be enrolled)
References
Publications (1)
- DERIVEDGunzer K, Joly F, Ferrero JM, Gligorov J, de Mont-Serrat H, Uttenreuther-Fischer M, Pelling K, Wind S, Bousquet G, Misset JL. A phase II study of afatinib, an irreversible ErbB family blocker, added to letrozole in patients with estrogen receptor-positive hormone-refractory metastatic breast cancer progressing on letrozole. Springerplus. 2016 Jan 19;5:45. doi: 10.1186/s40064-015-1601-7. eCollection 2016. PMID 26835225